Prospective Observational Study on the Effectiveness of Daridorexant in Chronic Insomnia in a Rea… (NCT07132086) | Clinical Trial Compass
CompletedNot Applicable
Prospective Observational Study on the Effectiveness of Daridorexant in Chronic Insomnia in a Real-World Setting
Italy31 participantsStarted 2023-10-01
Plain-language summary
The primary objectives of this study is to evaluate the real-world effectiveness of daridorexant 50 mg in improving both subjective (self-report) and objective (actigraphic) sleep parameters in patients with chronic insomnia.
The secondary aims of this study are:
* To compare the effectiveness of daridorexant 50 mg with other guideline-recommended therapies for chronic insomnia in improving sleep parameters and sleep health.
* To identify clinical and demographic predictors of response to daridorexant 50 mg, such as age, sex, BMI, duration of insomnia, and treatment regimen (monotherapy vs. add-on).
* To monitor changes over time in the symptoms related to comorbid sleep disorders (e.g., OSA, RLS, circadian rhythm disorders) in patients treated with daridorexant 50 mg.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Age ≥ 18 years
* Signed informed consent form
* Diagnosis of chronic insomnia according to DSM-5 criteria, defined as:
Dissatisfaction with sleep quantity or quality, associated with one or more of the following:
Difficulty initiating sleep
Difficulty maintaining sleep (frequent awakenings or trouble returning to sleep)
Early morning awakenings with inability to return to sleep
The sleep disturbance causes clinically significant distress or impairment in social, occupational, educational, academic, or other important areas of functioning
Sleep difficulties occur despite adequate opportunity and circumstances for sleep
The insomnia is not better explained by or occurring exclusively during other sleep-wake disorders (e.g., narcolepsy, parasomnias, circadian rhythm sleep-wake disorders, breathing-related sleep disorders)
The insomnia is not attributable to the physiological effects of a substance (e.g., drug abuse or medication)
\- No contraindications to daridorexant use according to the European Medicines Agency (EMA)
Exclusion Criteria:
* Pregnancy
* Breastfeeding
* Withdrawal of informed consent at any time
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in total sleep time after 3 months of daridorexant treatment
Timeframe: From baseline (Day 0) to 3 months after treatment initiation
2
Change in wake after sleep onset after 3 months of daridorexant treatment
Timeframe: From baseline (Day 0) to 3 months after treatment initiation
3
Change in sleep efficiency after 3 months of daridorexant treatment
Timeframe: From baseline (Day 0) to 3 months after treatment initiation
4
Change in sleep regularity index after 3 months of daridorexant treatment
Timeframe: From baseline (Day 0) to 3 months after treatment initiation
5
Change in self-reported sleep questionnaires after 3 months of daridorexant treatment
Timeframe: From baseline (Day 0) to 3 months after treatment initiation